Coordinator, QAIP QS5

APOTEX; Richmond Hill; On-site; CAD 49,000 - 81,000; Full time

Job summary

APOTEX in Canada (Richmond Hill) is seeking a QA professional to support GMP-compliant manufacturing, batch review, and QA documentation within the QAIP department.

You will operate SAP, LIMS, and TrackWise, participate in investigations and CAPAs, and provide cross-functional QA support to ensure compliant, on-time release of sterile and non-sterile products.

Qualifications

• Must be familiar with GMP and quality requirements.
• Strong English verbal and written communication skills.
• Excellent organizational skills and ability to manage time effectively.
• Ability to follow instructions according to written procedures.

Responsibilities

• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• Have required working knowledge to operate SAP, LIMS, and Trackwise systems.
• Quality Systems: Provide support to investigations and implementation of CAPAs within the QAIP department.
• Work as a team member along with Coordinators / Production to achieve all tasks / activities required to adequately investigate and address the non-conformances and prevent reoccurrence.
• Generate investigations as an observing department when deviations from established procedures or acceptance criteria are observed.
• Document Review: Review and approve applicable sterile and non-sterile Production documents according to established priorities and standards.
• Record the receipt, the review and the release of all batches in QA Supply Database to ensure that batches are appropriately processed through the supply chain.
• Oversee the control and archiving of production / packaging logbooks and also review for completeness and provide feedback where applicable.
• Quality Support: Provide QA oversight of all activities on the Production lines ensuring that established document and procedural requirements are followed by performing on-line batch document review to ensure full compliance with established Apotex procedures and GMP requirements.
• Perform sampling, inspection and review of physical testing on in-process / investigational samples and reporting of results in SAP and LIMS where applicable for completeness.
• Provide support to the Coordinator, QA In-Process QS7 in the regularly scheduled inspection / audits of the production / packaging area.
• Support customer complaint investigations as required.
• Validation (Cleaning Validation): Support the cleaning validation program by coordinating and performing sampling of equipment for cleaning validation, verification and monitoring activities as per Apotex procedures and GMP requirements.
• QAIP Support Activities: Performs reserve sample inspections and waste disposal as required.
• Log in samples into SAP and forward them to the required testing laboratories of QC or Microbiology.
• Ensure that individual training records are accurate and completed according to cGMP.

Skills

GMP knowledge

Quality systems

Attention to detail

English communication

Team collaboration

Word, Excel

Education

Diploma or degree in related discipline

Tools

SAP

LIMS

TrackWise

Job description

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Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

• Responsible for ensuring that quality products (including compounding, and sterile and non-sterile filling and packaging) are manufactured and packaged according to Good Manufacturing Practices (GMP) and established Standard Operating Procedures (SOP)
• Responsible to provide on-going quality oversight and direct support of quality systems in the areas of in-process bulk testing and batch record review
• Responsible for the collection and delivery of cleaning validation samples, and the completion of the required documentation for validation activity

Job Responsibilities

• Works in a safe manner collaborating as a team member to achieve all outcomes
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
• Have required working knowledge to operate SAP, LIMS, and Trackwise systems
• Quality Systems
• Provide support to investigations and implementation of CAPAs within the QAIP department
• Work as a team member along with Coordinators / Production to achieve all tasks / activities required to adequately investigate and address the non-conformances and prevent reoccurrence
• Generate investigations as an observing department when deviations from established procedures or acceptance criteria are observed
• Report any deviations found during review of sterile and non-sterile in process batch documents to the Coordinator, QA In-Process QS7 / Supervisor / Production personnel. Ensure all document corrections are made in the appropriate manner and ensure that all deviations are fully explained and supported by the necessary documentation
• Document Review
• Review and approve applicable sterile and non-sterile Production documents according to established priorities and standards
• Record the receipt, the review and the release of all batches in QA Supply Database to ensure that batches are appropriately processed through the supply chain in order to meet compliance and business requirements
• Oversee the control and archiving of production / packaging logbooks and also review for completeness and provide feedback where applicable
• Quality Support
• Provide QA oversight of all activities on the Production lines ensuring that established document and procedural requirements are followed by performing on-line batch document review to ensure full compliance with established Apotex procedures and GMP requirements
• Perform sampling, inspection and review of physical testing on in-process / investigational samples and reporting of results in SAP and LIMS where applicable for completeness
• Provide support to the Coordinator, QA In-Process QS7 in the regularly scheduled inspection / audits of the production / packaging area
• Support customer complaint investigations as required
• Validation (Cleaning Validation)
• Support the cleaning validation program by coordinating and performing sampling of equipment for cleaning validation, verification and monitoring activities as per Apotex procedures and GMP requirements
• QAIP Support Activities
• Performs reserve sample inspections and waste disposal as required
• Log in samples into SAP and forward them to the required testing laboratories of QC or Microbiology
• Ensure that individual training records are accurate and completed according to cGMP
• Provides training to new Coordinators
• All other relevant duties as assigned.

Job Requirements

• Education
  • Community College Diploma / University degree (or equivalent) in a related discipline
• Knowledge, Skills and Abilities
  • Must be familiar and knowledgeable with GMP and quality requirements
  • Strong English verbal and written communication skills
  • Excellent organizational skills and ability to manage time effectively
  • Ability to follow instructions according to written procedures
  • Ability to manage multiple priorities in a fast-paced and changing environment
  • Demonstrated ability to work individually and in a team environment
  • Familiarity with Word, Excel, Access would be an asset
  • Flexibility to work shifts
• Experience
• Minimum 2 years of experience in a pharmaceutical quality and / or production environment

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

The hiring range for this position is $48,851 - $81,419 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.
We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.
The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.